The following data is part of a premarket notification filed by Visage Imaging Gmbh with the FDA for Visage Ease Pro.
Device ID | K142196 |
510k Number | K142196 |
Device Name: | Visage Ease Pro |
Classification | System, Image Processing, Radiological |
Applicant | VISAGE IMAGING GMBH LEPSIUSTRASSE 70 Berlin, DE 12163 |
Contact | Stefan Strowich |
Correspondent | Stefan Strowich VISAGE IMAGING GMBH LEPSIUSTRASSE 70 Berlin, DE 12163 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-11 |
Decision Date | 2015-04-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04251332920016 | K142196 | 000 |
04251332920009 | K142196 | 000 |
04251332920023 | K142196 | 000 |
04251332920030 | K142196 | 000 |
04251332920047 | K142196 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VISAGE EASE PRO 87036252 5122442 Live/Registered |
PME IP Pty Ltd 2016-05-13 |
VISAGE EASE PRO 86857980 5189117 Live/Registered |
PME IP Pty Ltd 2015-12-27 |
VISAGE EASE PRO 86631759 5151841 Live/Registered |
PME IP PTY LTD 2015-05-15 |